NCT00433095已完成2 期
Vinorelbine (Oral) Plus Trastuzumab for 1st-line Treatment of HER2/Neu Overexpressing Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Response rate
研究概览
简要总结
1st-line treatment of HER2/neu overexpressing breast cancer
详细描述
The combination of vinorelbine and trastuzumab was demonstrated to be highly effective in several trials showing response rates in the range of 59-78%. This combination is characterized by good tolerability and can be applied for a prolonged period without the risk of major cumulative toxicity The availability of oral vinorelbine promises a further simplification of therapy. The present trial therefore investigates the safety and efficacy of a combined treatment with trastuzumab and oral vinorelbine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven, metastatic breats cancer.
- •HER2-neu overexpression (IHC3+ or IHC2+/FISH+)
- •Written informed consent
- •no previous therapy with vinorelbine or trastuzumab
- •Age * 18 and * 75 years
- •Karnofsky-Performance status > 70%
- •Life expectance 16 weeks and more
- •Availability of at least one target lesion according to RECIST-criteria. Target lesions need to be outside of radiation fields. Bone metastases are excluded as indicator leasions
- •Exclusion of pregnancy and adequte contraception during childbearing age.
- •Adequate hematological, renal, and hepatic function
- •Normal cardiac function. LVEF should not be >10% below normal.
- •Adequate compliance to perform treatment and subsequent follow-up visits
排除标准
- •Locoregional recurrence of breast cancer only or development of contralateral breast cancer
- •Pregnancy or lactation
- •Symptomatic brain- or meningeal metastasis
- •Concurrent endocrine antitumor therapy
- •Other malignancies except basal cell cancer of the skin or in-situ carcinoma of the cervix
- •Peripheral neuropathy >= NCI CTC Grade
- •other severel disease which preclude adequate treatment
- •Participation in a clinical trial within the last 30 days.
- •Psychological, familial, sociological or geographical conditions which preclude treatment according to the protocol or the planned follow-up
结局指标
主要结局
Response rate
次要结局
- Time to tumor progression
- Overall survival
- Safety
研究者
研究点 (2)
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